Notice2024-28755
Impact of the Implementation of the Chemical Weapons Convention (CWC) on Legitimate Commercial Chemical, Biotechnology, and Pharmaceutical Activities Involving “Schedule 1” Chemicals (Including “Schedule 1” Chemicals Produced as Intermediates) During Calendar Year 2024
Primary source
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Published
December 9, 2024
Issuing agencies
Commerce DepartmentIndustry and Security Bureau
Abstract
The Bureau of Industry and Security (BIS) is seeking public comments on the impact that implementation of the Chemical Weapons Convention (CWC or "the Convention"), through the Chemical Weapons Convention Implementation Act of 1998 and the Chemical Weapons Convention Regulations (CWCR), has had on commercial activities involving "Schedule 1" chemicals during calendar year 2024. The purpose of this notice of inquiry is to collect information to assist BIS in its preparation of the annual certification to the Congress on whether the legitimate commercial activities and interests of chemical, biotechnology, and pharmaceutical firms are harmed by such implementation. This certification is required under Condition 9 of Senate Resolution 75 (April 24, 1997), in which the Senate gave its advice and consent to the ratification of the CWC.
Full Text
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<title>Federal Register, Volume 89 Issue 236 (Monday, December 9, 2024)</title>
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[Federal Register Volume 89, Number 236 (Monday, December 9, 2024)]
[Notices]
[Pages 97583-97584]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28755]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
[Docket No. 241127-0304]
RIN 0694-XC110
Impact of the Implementation of the Chemical Weapons Convention
(CWC) on Legitimate Commercial Chemical, Biotechnology, and
Pharmaceutical Activities Involving ``Schedule 1'' Chemicals (Including
``Schedule 1'' Chemicals Produced as Intermediates) During Calendar
Year 2024
AGENCY: Bureau of Industry and Security, Commerce.
ACTION: Notice of inquiry.
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SUMMARY: The Bureau of Industry and Security (BIS) is seeking public
comments on the impact that implementation of the Chemical Weapons
Convention (CWC or ``the Convention''), through the Chemical Weapons
Convention Implementation Act of 1998 and the Chemical Weapons
Convention Regulations (CWCR), has had on commercial activities
involving ``Schedule 1'' chemicals during calendar year 2024. The
purpose of this notice of inquiry is to collect information to assist
BIS in its preparation of the annual certification to the Congress on
whether the legitimate commercial activities and interests of chemical,
biotechnology, and pharmaceutical firms are harmed by such
implementation. This certification is required under Condition 9 of
Senate Resolution 75 (April 24, 1997), in which the Senate gave its
advice and consent to the ratification of the CWC.
DATES: Comments must be received by January 8, 2025.
ADDRESSES: Comments on this rule may be submitted to the Federal
rulemaking portal at: <a href="http://www.regulations.gov">www.regulations.gov</a>. The <a href="http://regulations.gov">regulations.gov</a> ID for
this rule is: BIS-2024-0054. Please refer to RIN 0694-XC110 in all
comments.
All filers using the portal should use the name of the person or
entity submitting the comments as the name of their files, in
accordance with the instructions below. Anyone submitting business
confidential information should clearly identify the business
confidential portion at the time of submission, file a statement
justifying nondisclosure and referring to the specific legal authority
claimed, and provide a non-confidential version of the submission.
For comments submitted electronically containing business
confidential information, the file name of the business confidential
version should begin with the characters ``BC.'' Any page containing
business confidential information must be clearly marked ``BUSINESS
CONFIDENTIAL'' on the top of that page. The corresponding non-
confidential version of those comments must be clearly marked
``PUBLIC.'' The file name of the non-confidential version should begin
with the character ``P.'' Any submissions with file names that do not
begin with either a ``BC'' or a ``P'' will be assumed to be public and
will be made publicly available at: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Commenters submitting business confidential information are
encouraged to scan a hard copy of the non-confidential version to
create an image of the file, rather than submitting a digital copy with
redactions applied, to avoid inadvertent redaction errors which could
enable the public to read business confidential information.
FOR FURTHER INFORMATION CONTACT:
For questions on the Chemical Weapons Convention requirements for
``Schedule 1'' chemicals, contact David Johnston, Treaty Compliance
Division, (202) 482-2450, Email: David <a href="/cdn-cgi/l/email-protection#bff5d0d7d1cccbd0d1ffddd6cc91dbd0dc91d8d0c9"><span class="__cf_email__" data-cfemail="02486d6a6c71766d6c42606b712c666d612c656d74">[email protected]</span></a>.
For questions on the submission of comments, contact Logan Norton,
Regulatory Policy Division, (202) 482-2440; Email: <a href="/cdn-cgi/l/email-protection#643634205624060d174a000b074a030b12"><span class="__cf_email__" data-cfemail="3062607402705259431e545f531e575f46">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
In providing its advice and consent to the ratification of the
Convention on the Prohibition of the Development, Production,
Stockpiling, and Use of Chemical Weapons and Their Destruction (CWC or
``the Convention''), the Senate included, in Senate Resolution 75 (S.
Res. 75, April 24, 1997), several conditions to its ratification.
Condition 9, titled ``Protection of Advanced Biotechnology,'' calls for
the President to certify to Congress on an annual basis that ``the
legitimate commercial activities and interests of chemical,
biotechnology, and pharmaceutical firms in the United States are not
being significantly harmed by the limitations of the Convention on
access to, and production of, those chemicals and toxins listed in
Schedule 1.'' On July 8, 2004, President George W. Bush, by Executive
Order 13346, delegated his authority to make the annual certification
to the Secretary of Commerce.
The CWC is an international arms control treaty that contains
certain verification provisions. In order to implement these
verification provisions, the CWC established the Organization
[[Page 97584]]
for the Prohibition of Chemical Weapons (OPCW). In order to achieve the
object and purpose of the Convention and the implementation of its
provisions, the CWC imposes certain obligations on countries that have
ratified the Convention (i.e., States Parties), among which are the
enactment of legislation to prohibit the production, storage, and use
of chemical weapons and the establishment of a National Authority to
serve as the national focal point for effective liaison with the OPCW
and other States Parties. The CWC also requires each State Party to
implement a comprehensive data declaration and inspection regime to
provide transparency and to verify that both the public and private
sectors of the State Party are not engaged in activities prohibited
under the CWC. In the United States, the Chemical Weapons Convention
Implementation Act of 1998 (22 U.S.C. 6701 et seq.) implements the
provisions of the CWC.
``Schedule 1'' chemicals consist of those toxic chemicals and
precursors set forth in the CWC ``Annex on Chemicals'' and in
``Supplement No. 1 to part 712--SCHEDULE 1 CHEMICALS'' of the CWCR (15
CFR parts 710-722). The CWC identified these toxic chemicals and
precursors as posing a high risk to the object and purpose of the
Convention.
The CWC (Part VI of the ``Verification Annex'') restricts the
production of ``Schedule 1'' chemicals for protective purposes to two
facilities per State Party: a single small-scale facility and a
facility for production in quantities not exceeding 10 kilograms (kg)
per year. The CWC Article-by-Article Analysis submitted to the Senate
in Treaty Doc. 103-21 defined the term ``protective purposes'' to mean
``used for determining the adequacy of defense equipment and
measures.'' Consistent with this definition and as authorized by
Presidential Decision Directive (PDD) 70 (December 17, 1999), which
specifies agency and departmental responsibilities as part of the U.S.
implementation of the CWC, the Department of Defense (DoD) was assigned
the responsibility to operate these two facilities. DoD maintains
strict controls on ``Schedule 1'' chemicals produced at its facilities
in order to ensure accountability for such chemicals, as well as their
proper use, consistent with the object and purpose of the Convention.
Although this assignment of responsibility to DoD under PDD-70
effectively precluded commercial production of ``Schedule 1'' chemicals
for ``protective purposes'' in the United States, it did not establish
any limitations on ``Schedule 1'' chemical activities that are not
prohibited by the CWC.
The provisions of the CWC that affect commercial activities
involving ``Schedule 1'' chemicals are implemented in the CWCR (see 15
CFR part 712) and in the Export Administration Regulations (EAR) (see
15 CFR 742.18 and 15 CFR part 745), both of which are administered by
BIS. Pursuant to CWC requirements, the CWCR restrict commercial
production of ``Schedule 1'' chemicals to research, medical, or
pharmaceutical purposes. The CWCR prohibit commercial production of
``Schedule 1'' chemicals for ``protective purposes'' because such
production is effectively precluded per PDD-70, as described above (see
15 CFR 712.2(a)).
The CWCR also contain other requirements and prohibitions that
apply to ``Schedule 1'' chemicals and/or ``Schedule 1'' facilities.
Specifically, the CWCR:
(1) Prohibit the import of ``Schedule 1'' chemicals from States not
Party to the Convention (15 CFR 712.2(b));
(2) Require annual declarations by certain facilities engaged in
the production of ``Schedule 1'' chemicals in excess of 100 grams
aggregate per calendar year (i.e., declared ``Schedule 1'' facilities)
for purposes not prohibited by the Convention (15 CFR 712.5(a)(1) and
(a)(2));
(3) Provide for government approval of ``declared Schedule 1''
facilities (15 CFR 712.5(f));
(4) Require 200 days advance notification of the establishment of
new ``Schedule 1'' production facilities producing greater than 100
grams aggregate of ``Schedule 1'' chemicals per calendar year (15 CFR
712.4);
(5) Provide that ``declared Schedule 1'' facilities are subject to
initial and routine inspection by the OPCW (15 CFR 712.5(e) and
716.1(b)(1));
(6) Require advance notification and annual reporting of all
imports and exports of ``Schedule 1'' chemicals to, or from, other
States Parties to the Convention (15 CFR 712.6, 742.18(a)(1) and
745.1); and
(7) Prohibit the export of ``Schedule 1'' chemicals to States not
Party to the Convention (15 CFR 742.18(a)(1) and (b)(1)(ii)).
For purposes of the CWCR (see the definition of ``production'' in
15 CFR 710.1), the phrase ``production of a Schedule 1 chemical'' means
the formation of ``Schedule 1'' chemicals through chemical synthesis,
as well as processing to extract and isolate ``Schedule 1'' chemicals.
The phrase also encompasses the formation of a chemical through
chemical reaction, including by a biochemical or biologically mediated
reaction. ``Production of a Schedule 1 chemical'' is understood, for
CWCR declaration purposes, to include intermediates, by-products, or
waste products that are produced and consumed within a defined chemical
manufacturing sequence, where such intermediates, by-products, or waste
products are chemically stable and therefore exist for a sufficient
time to make isolation from the manufacturing stream possible, but
where, under normal or design operating conditions, isolation does not
occur.
Request for Comments
In order to assist in determining whether the legitimate commercial
activities and interests of chemical, biotechnology, and pharmaceutical
firms in the United States are significantly harmed by the limitations
of the Convention on access to, and production of, ``Schedule 1''
chemicals as described in this notice, BIS is seeking public comments
on any effects that implementation of the CWC, through the Chemical
Weapons Convention Implementation Act of 1998 and the CWCR, has had on
commercial activities involving ``Schedule 1'' chemicals during
calendar year 2024. To allow BIS to properly evaluate the significance
of any harm to commercial activities involving ``Schedule 1''
chemicals, public comments submitted in response to this notice of
inquiry should include both a quantitative and qualitative assessment
of the impact of the CWC on such activities.
Submission of Comments
All comments must be submitted to one of the addresses indicated in
this notice and in accordance with the instructions provided herein.
BIS will consider all comments received on or before January 8, 2025.
Matthew S. Borman,
Principal Deputy Assistant Secretary for Strategic Trade and Technology
Security.
[FR Doc. 2024-28755 Filed 12-6-24; 8:45 am]
BILLING CODE 3510-33-P
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